MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RUNTHROUGH NS; WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported an out of box failure for the g-260-2527 a viziglide wire involved.During the procedure the g-260-2527 a snagged the elevator of the t jf-q 190v and the wire snapped.The procedure was able to be completed using a second g-260-2527 a wire.This was an out of box failure.Additional information was received on 11 jan 2023: the procedure performed was an endoscopic retrograde cholangiopancreatography (ercp).The event occurred intra-operative.The procedure was completed with a second device.The patient was in stable condition.The procedure was successful.There was no blood loss.The device broke outside the body.The user of the device was able to pull the device back thru the scope when it looked damaged at approximately 6-7cm from the distal tip.

• Brand Name: RUNTHROUGH NS
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 16169852
• Report Number: 2243441-2022-00032
• Device Sequence Number: 12372318
• Product Code: DQX
• UDI-Device Identifier: 54953170358208
• UDI-Public: 54953170358208
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/14/2023
• Report Date (Section F): 01/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: N/A
• Device Catalogue Number: OL-XA25275M
• Device Lot Number: 25K (220512)
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/16/2022
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/22/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/14/2023